Leonardo Mini Blue— 510(k) K210951

Substantially Equivalent

Ceramoptec GmbH

FDA 510(k) clearance K210951 for Leonardo Mini Blue, Substantially Equivalent on 2021-09-01. Applicant: Ceramoptec GmbH.

Clearance details

Applicant: Ceramoptec GmbH
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2021-03-30
Decision date: 2021-09-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bonn, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.